Super's Diana S.L. — EU GMP NCR (EudraGMDP) Findings

- Pharmaceutical quality system implemented in the company does not allow for adequate identification of risks and the adoption of the necessary measures to avoid them and ensure the quality of the medicinal products manufactured in the facility. Deviations, OOS, OOT management is very poor and no appropriate corrective and preventive actions are taken in response to the investigations. - The Company has not enough qualified personnel to be able to manage the Pharmaceutical Quality System to assure an adequate level of quality and safety for the veterinary medicines manufactured. - There is a lack of sterility assurance, including mayor deficiencies involving the aseptic process simulation (APS), as well as several deficiencies with Annex 1 of the EU GMP Guidelines in relation with non-viable and viable particle monitoring, sterility of primary packaging, qualification of sterile manufacturing rooms, sterilizing filters, among others. - Facilities are not adequately designed to provide assurance for the activities carried out and a poor state of maintenance was observed. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. 0728 in Part Recall of batches already released No specific quality defects on concrete batches present in the market were detected, and thus no action/recall is deemed necessary against concrete batches released and placed on the market. Recall of medicinal product is not suggested or it should be evaluated by the involved NCAs’ following assessment conducted in conjunction with MAHs, if there are alternative suppliers and there is no risk of shortage.